OPQ’s FY2021 report gives mixed review on state of drug quality

Regulatory NewsRegulatory News | 30 August 2022 |  By 

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lists both negative and positive trends in its new report assessing the state of pharmaceutical quality in FY2021. Among the setbacks are the increasing number of drug recalls, under-reporting of quality issues in field alert reports (FARs) and a growing number of products failing sampling tests.
On the bright side, OPQ said its New Inspection Protocol Project (NIPP) program has increased the efficiency of inspections through a more targeted and data-driven approach to identify potential quality problems early on. Also, sites making “essential medicines” protecting the public against outbreaks of emerging diseases such as COVID-19, have high median site inspection scores (SIS) indicating a high rate of compliance with good manufacturing practices (GMPs).
The fourth annual report from OPQ addresses manufacturing site demographics, drug product demographics, product quality defects, import alerts and recalls and research on the state of drug quality.
Growing number of recalls
The report shows that for the second year, the number of total recalls – particularly Class I recalls – have increased. This follows a three-year period of declining recalls from FY2017 to FY2019. Since FY2016, recalls spiked up dramatically, going from roughly 300 recalls events a year in 2019 to 700 in FY2020 to 800 in FY2021.
The increase is attributed to Class I recalls of hand sanitizers that contained methanol, as well as consumer products and sunscreens with benzene contamination. Yet Class II recalls “have not shown any trends.” These recalls tend to be “event driven and reflect emerging knowledge of product defects,” while Class III recalls “have been steady.”
Firms not submitting field alert reports
The report also found that roughly half (49.1%) of 1,143 eligible firms did not submit FARs to the agency over a four-year period from FY2018 to FY2021. FDA’s postmarket reporting requirements specify that sites submit FARs after receiving information on significant quality problems with their distributed drug products.
Sites that did not submit FARs tended to be foreign firms, were companies producing non-sterile products or had fewer approved applications.
The report notes that, “In general, OPQ recognizes FAR submissions as an attribute of a healthy pharmaceutical quality system.”
Rate of non-compliant samples increased
In other areas, the report found that a growing number of products are failing sampling and testing requirements, a method of inspection is used when FDA cannot get to sites to conduct inspections. In FY2021, the percent of non-compliant samples grew to 35%, an increase from 16% in FY2020.
The growing rate of non-compliance “is driven by focused sampling assignments with high non-compliant rates for products with nitrosamine contamination, hand sanitizers, and sampling related to COVID-19 mission critical sampling and testing, which became more prominent in FY2021. “
NIPP enhances inspections
In a positive development, FDA said its NIPP program has “improved how data from pre-approval and surveillance inspections are evaluated and reported.” FDA has been using these inspection protocols for certain sterile surveillance and pre-approval inspections since 2018. (RELATED: FDA Looks to Modernize Sterile Injectable Inspections, Regulatory Focus 9 November 2018)
These protocols collect structured data for each system of a surveillance inspection or for each objective of a pre-approval inspection, and answers to questions are scored on three levels” written observations on a Form 483, a verbal discussion item or no objectionable conditions.
The structured data obtained from NIPP “may expand predictive capabilities for quality surveillance and help protect patients from potential supply disruptions.”
For example, data from NIPP protocols collected during inspections show a high number of FDA Form 483 observation reports went to manufacturers following their answers to protocol questions related to their handling of investigations. The report found that 34 reports went to firms related to investigations, followed by 20 observations for quality unit oversight and 17 for corrective and preventive action (CAPA) activities.
Essential medicines have high quality scores
The report also found that sites making essential medicines have high median site inspection scores (SIS).
The list of essential medicines includes 227 drug and biological products such as analgesics, antivirals, anticoagulants, antihypertensives and antimicrobials. FDA’s site catalogue includes approximately 1,100 sites that manufacture at least one product on the essential medicines list.
An analysis of active pharmaceutical ingredient (API) and finished dosage form (FDF) sites found that the median SIS for essential medicine manufacturers was 7.45 out of 10, a score that was “significantly higher” than the 7.0 score for non-essential medicine manufacturers. “This observation indicates that sites manufacturing EM products have a higher level of adherence to manufacturing compliance standards than sites that do not manufacture EM products,” OPQ wrote.
FDA’s site catalogue reflected 4,451 drug manufacturing sites, a 3% increase over FY2018, as of November 2021. The increase was attributed to newly registered sites that manufacture non-alcohol-based hand sanitizers or hand sanitizers in other dosage forms such as wipes and aerosols.
Of the total drug manufacturing sites in FY2021, 39% were in the “No Application” sector, meaning products manufactured without an approved FDA application, including OTC drugs, marketed unapproved prescription drug products and homeopathic products. The remaining 61% manufacture either biological products licensed under a biologics license application (BLA), new products marketed under new drug applications (NDA) or generic products approved under abbreviated new drug applications (ANDA).
The state of quality report for 2020 was issued in August 2021. (RELATED: FDA report: Drug quality tops OPQ’s list of product defects, Regulatory Focus 19 August 2021)
OPQ FY 2021 state of quality report


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